January 22, 1987 
IBA 
Industrial 
Biotechnology 
Association 
1625 K Street. N W 
Suite 1100 
Washington, D C. 20006 
(202) 857 0244 
FAX (202)857 0237 
Dr. William J. Gartland, Jr. 
Executive Secretary 
Recombinant DNA Advisory Committee 
National Institutes of Health 
Building 31, Room 3B10 
Bethesda, MD 20892 
Alan R. Goldhammer. Ph D. 
Director o( 
Technical Allans 
Re: Proposed Revisions of NIH Guidelines 
Dear Dr. Gartland: 
Dirvctora 
Off* c*r» 
CtW irman 
G torgr B Rjihrrunn 
A/ngrn 
Vic* Chairman 
Hug* A. O'Ardradr 
Sctwrmq Plough Corp 
Srcr.forv 
John R Norefl 
PhJIipy Petroleum Co 
T reawrn 
Jerry O Caulder 
Mytoqen Corporation 
Ronald E Cape 
C«us Corporation 
Will 0 Carpenter 
Monsanto Company 
Ralph E Chnstolfenen 
The Uprohn Company 
Nicholas M Frey 
Pioneer H Bred 
International. Inc 
L Patrick Gaqe 
Hotfmann La Roche. Inc 
Ralph W F Hardy 
BnTechraca International. Inc 
David A Jackson 
E I du Pom de Nemours & Co 
Gabnrl Schmergel 
CenetKS Institute. Inc 
Hubert J P Schoemaker 
Centocor 
Robert A Swanson 
Genentech. Inc 
These comments on the proposed revisions of the NIH Guidelines 
for Recombinant DNA Research to be discussed at the February 2 NIH 
Recombinant DNA Advisory Committee (NIH-RAC) meeting are submitted 
on behalf of the Industrial Biotechnology Association (IBA). IBA 
is a trade association of 56 member companies engaged in 
biotechnology ventures. A current membership roster is attached to 
this letter. 
IBA supports all four of the revisions as set forth in the 
Federal Register of December 19 (51 FR 45650). These revisions 
will provide needed clarification in several areas. The new 
definitions will make the Guidelines less ambiguous in regards to 
the types of genetically altered organisms that will fall under its 
purview. Additionally, the role of the various federal regulatory 
agencies will be explicitly recognized under the changes proposed. 
Specific comments to the proposed revisions are given below. 
SECTION I 
The changes outlined in this section, proposed by Dr. Bernard 
Talbot, recognize that various federal regulatory agencies have 
specific statutory authority to review products created through 
recombinant DNA technology. Implementation of this change will 
eliminate the requirement for possible dual reviews when that 
product is reviewed by the appropriate regulatory agency. IBA 
believes that the authority of the various regulatory agencies and 
NIH was set out in the Coordinated Framework for Regulation of 
Biotechnology (51 FR 23302). This new wording brings the 
Guidelines into accord with that framework. 
Recombinant DNA Research, Volume 1 1 
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